Nicotine powder delivery system

ABSTRACT

A nicotine powder delivery system includes an inhaler article and a nicotine powder capsule disposed within the inhaler article. The nicotine powder capsule rotates about a longitudinal axis when air flows through the inhaler article.

This application is the § 371 U.S. National Stage of InternationalApplication No. PCT/IB2016/057455, filed 8 Dec. 2016, which claims thebenefit of European Patent Application No. 15202712.4, filed 24 Dec.2015, the disclosures of which are incorporated by reference herein intheir entireties.

This disclosure relates to nicotine powder delivery system that includesan inhaler article and a nicotine powder capsule disposed within theinhaler article. The nicotine powder capsule may rotate about alongitudinal axis when air flows through the inhaler article.

Dry powder inhalers (DPI) are known and are used to treat respiratorydiseases by delivering a dry powder comprising a pharmaceutical, inaerosol form through inhalation to the patients' airways. For deliveryinto the lungs, particles in the range of 1 to 5 micrometers arepreferred. In pharmaceutical dry powders, the active pharmaceuticalingredient (API) is agglomerated on the surface of larger carrierparticles, such as lactose for example. DPI's operate complex mechanismsto ensure such agglomerates disperse, break up or disaggregate beforethe API can be inhaled into the lungs. Pharmaceutical dry powderscontaining lactose as a carrier can be in the range of 20 to 100micrometers.

DPI's rely on the force of the patients' inhalation to entrain thepowder from the device to subsequently break-up the powder intoparticles that are small enough to enter the lungs. Sufficiently highinhalation rates are required to ascertain correct dosing and completedisaggregation of the powder. Typically a large amount of API remainsattached on the surface of the carrier and is deposited in the upperairways due to incomplete de-aggregation of the powder. Inhalation ratesof existing DPI's are usually in the range of 20-100 liters/min (L/min).Existing DPI's are therefore only suitable for delivering dry powders tousers in a manner that is different from the inhalation rate associatedwith smoking articles.

It would be desirable to provide a nicotine powder delivery system thatprovides nicotine particles to the lungs at inhalation or air flow ratesthat are within conventional smoking regime inhalation or air flowrates. It would also be desirable to provide deliver the nicotine powdersystem with an inhaler article that is a similar size and configurationas a conventional cigarette.

A nicotine powder delivery system includes an inhaler article and anicotine powder capsule disposed within the inhaler article. Air flowmanagement through the inhaler article may cause the pierceable nicotinepowder capsule to rotate and release nicotine powder into the air flow.

The inhaler article includes an inhaler body extending between amouthpiece portion and a distal end portion. A nicotine powderreceptacle is disposed within the inhaler body and between themouthpiece portion and the distal end portion. An air inlet port extendsthrough the inhaler body and into the nicotine powder receptacle. Amouthpiece air channel fluidly connects the nicotine powder receptaclewith a proximal end of the mouthpiece. A nicotine powder capsulecontaining nicotine powder is disposed within the nicotine powderreceptacle. The nicotine powder capsule may rotate about a longitudinalaxis when air flows from the air inlet port to the mouthpiece airchannel.

A ready-to-consume nicotine capsule containing nicotine powdercomprising particles comprising nicotine is described and may have onlya single aperture through the nicotine capsule for releasing anaerosolized nicotine powder through the single aperture.

A method of inhaling nicotine includes the step of inhaling air througha nicotine powder inhaler where the nicotine powder inhaler includes anicotine capsule having only a single aperture through the nicotinecapsule. Nicotine powder is released through the single aperture andinto the air, at an air flow rate of less than about 2 litres perminute, to deliver the nicotine powder to lungs of the user.

Advantageously, the nicotine powder delivery system described herein mayprovide a simple inhaler and capsule system that delivers nicotine atinhalation or air flow rates that are within conventional smoking regimeinhalation or air flow rates. Advantageously, the nicotine powderdelivery system may utilize a capsule having a single aperture fornicotine powder release. Advantageously, the single aperture may providea controlled release of nicotine powder with each inhalation or “puff”of the nicotine powder delivery system. Advantageously, the singleaperture may prevent a fast depletion of the nicotine powder.Advantageously, rotation of the nicotine powder capsule may suspend thenicotine powder and aerosolizes the nicotine powder in the inhalationair moving through the air flow channel of the inhaler article.

Flavour particles may be combined with the nicotine powder. Theseflavour particles may be larger than the nicotine particles and assistin transporting the nicotine particles into the lungs of the user whilethe flavour particles preferentially remain in the mouth or buccalcavity of the user.

The term “nicotine” refers to nicotine and nicotine derivatives such asfree-base nicotine, nicotine salts and the like.

The term “flavourant” or “flavour” refers to organoleptic compounds,compositions, or materials that alter and are intended to alter thetaste or aroma characteristics of nicotine during consumption orinhalation thereof. The term “flavourant” or “flavour” preferably refersto compounds disclosed in the Flavor & Extract Manufacturers Association(FEMA) Flavor Ingredient Library and in particular in the GRAS FlavoringSubstances publications 3 to 27, for example, see Hall, R. L. & Oser, B.L., Food Technology, February 1965 pg 151-197, and in the GRAS flavoringsubstances 27 S. M. Cohen et al., Food Technology August 2015 pg. 40-59,and intervening GRAS Flavoring Substances publications 4 to 26. For thepurpose of this disclosure, nicotine is not considered as a flavourantor flavour.

The size of a particle, stated herein, preferably refers to theaerodynamic diameter of the particle. The aerodynamic diameter of apowder system is preferably measured with a cascade impactor.

This disclosure relates to nicotine powder delivery systems that includean inhaler article and a nicotine powder capsule containing nicotinepowder is disposed within the inhaler article. The nicotine powdercapsule may rotate about a longitudinal axis when air flows through theinhaler article. The nicotine powder capsule may be pierced to form onlya single aperture (or no more than one aperture or less than twoapertures) through the nicotine powder capsule. Nicotine powder andoptional flavour particles may exit the single aperture duringconsumption. Air flow management though the inhaler article may causethe nicotine powder capsule to rotate or spin within the nicotine powderreceptacle and release an aerosol of nicotine powder and optionalflavour particles into the mouthpiece channel for delivery to the user.

The nicotine powder delivery system provides nicotine particlespreferentially to the lungs of a user and optional flavour particlespreferentially to the buccal or mouth cavity of a user. The relativeparticle sizes of the nicotine powder component and the optional flavourpowder component may remain stable even when combined with each otherand is preferably a free flowing powder. The nicotine powder may bedelivered with a simple inhaler construction at inhalation or air flowrates that are within conventional smoking regime inhalation or air flowrates.

The inhaler article includes an inhaler body extending between amouthpiece portion and a distal end portion and a nicotine powderreceptacle disposed within the inhaler body and between the mouthpieceportion and the distal end portion. An air inlet port extends throughthe inhaler body and into the nicotine powder receptacle. A mouthpieceair channel is fluidly connected to the nicotine powder receptacle and aproximal end of the mouthpiece. Preferably the inhaler body may resemblea cigarette.

The air inlet port may be arranged and configured to cause the nicotinepowder capsule to rotate or spin within the nicotine powder receptacle.The nicotine powder capsule may have an obround shape with circularcross-section extending a length along a central axis. The air inletport may direct air into the nicotine powder receptacle in a directionthat is substantially orthogonal to the longitudinal (central) axis ofthe nicotine powder capsule contained within the nicotine powderreceptacle.

The air inlet port may be off-set from the longitudinal (central) axisof the nicotine powder capsule contained within the nicotine powderreceptacle. The off-set air inlet may induce the nicotine powder capsuleto rotate or spin within the nicotine powder receptacle duringinhalation by the consumer. The air inlet port may be off-set from thelongitudinal (central) axis of the nicotine powder capsule by about 2mm, or about 3 mm, or about 4 mm. The one or more air inlet ports mayhave a diameter from about 0.5 to 1.5 mm, or about 0.7 to about 0.9 mm.Preferably, the air inlet port directs air tangent to the outer diameterof the nicotine powder capsule contained within the nicotine powderreceptacle.

The nicotine powder receptacle preferably may has a circularcross-sectional shape extending (a length distance) along its centralaxis and forming a cylindrical nicotine powder receptacle. Preferablythe nicotine powder receptacle defines a right circular cylinder with aradius and having a length extending along a central axis. The air inletport may enter the nicotine powder receptacle tangentially to thecylindrical nicotine powder receptacle. There are two air inlet portsthat enter the nicotine powder receptacle tangentially to thecylindrical nicotine powder receptacle. Preferably these air inlet portsoppose each other and the first air inlet port directs air tangentiallyto the cylindrical nicotine powder receptacle in a first direction andthe second air inlet port directs air tangentially to the cylindricalnicotine powder receptacle in a second direction that opposes or is inthe opposite direction as the first direction. These opposing air inletports may direct inhalation air at opposing sides of the nicotine powdercapsule contained within the nicotine powder receptacle promoting therotation of the nicotine powder capsule contained within the nicotinepowder receptacle.

The nicotine powder receptacle preferably may have a circularcross-sectional shape with a first diameter. The nicotine powder capsulecontained within the nicotine powder receptacle has a second diameterthat is less than the first diameter. Preferably, the second diameter(of the nicotine powder capsule) may be in a range from about 80% toabout 99%, or from about 90% to about 98% of the first diameter (of thenicotine powder receptacle). Preferably the diameter of the nicotinepowder capsule may be about 0.5 to about 2 mm less than the diameter ofthe nicotine powder receptacle or from about 1 to about 2 mm less thanthe diameter of the nicotine powder receptacle. The nicotine powderreceptacle may have a length in a range from about 10 mm to about 30 mm,or from about 15 mm to about 25 mm, or about 20 mm.

The end cap element may be formed of any pierceable material that has aresistance to draw (RTD) greater than about 120 mm WG or in a range fromabout 120 mm WG to about 200 mm WG or in a range from about 120 mm WG toabout 150 mm WG. One useful material forming the end cap element may becellulose acetate or high density cellulose acetate. As described below,a piercing element may pass through the end cap element and form asingle aperture through the wall of the nicotine powder capsule. Thematerial forming the end cap element may substantially close the holeformed in the material forming the end cap element once the piercingelement is removed from the piercing element. The end cap element mayhave a length in a range from about 2 mm to about 20 mm, or from about 5mm to about 15 mm, or from about 8 mm to about 12 mm, or about 10 mm.

The mouthpiece portion may be formed of any useful material. Themouthpiece portion has at least one airflow channel that fluidlyconnects the nicotine powder receptacle to the proximal end of themouthpiece. The mouthpiece portion may have at least two parallel andcoextensive airflow channels that fluidly connect the nicotine powderreceptacle to the proximal end of the mouthpiece. The one or moremouthpiece airflow channels have a diameter of at least about 0.5 mm,and may be in a range from about 0.5 mm to about 2 mm, or from about 1mm to about 2 mm. The one or more mouthpiece airflow channels maypreferably be linear along the length of the mouthpiece portion. Themouthpiece portion may have a length in a range from about 10 mm toabout 25 mm, or from about 10 mm to about 20 mm, or about 15 mm.

The nicotine powder delivery system may have an overall resistance todraw (RTD) that is less than 100 mm WG, or in a range from about 50 mmWG to about 100 mm WG. The nicotine powder delivery system may mimic theconfiguration of a cigarette. The nicotine powder delivery system orinhaler may have a length in a range from about 40 mm to about 110 mm,or from about 40 mm to about 80 mm and a diameter in a range from about5 mm to about 10 mm, or in a range from about 7 mm to about 8 mm.

A nicotine powder capsule may be disposed within the nicotine powderreceptacle. The nicotine powder capsule may be configured to rotateabout its longitudinal or central axis when air flows from the one ormore air inlet ports through the nicotine powder receptacle to themouthpiece air channel. The capsule may be formed of an airtightmaterial that may be pierced or punctured by the inhaler. The capsulemay formed of a metallic or polymeric material that serves to keepcontaminates out of the capsule but may be pierced or punctured by apiercing element prior to consumption of the powder within the capsule.The capsule may be formed of a polymer material. The polymer materialmay be hydroxypropylmethylcellulose (HPMC). Preferably, the capsule is asize 2 to size 4 capsule, or a size 3 capsule.

The nicotine powder capsule contains nicotine powder that comprisesnicotine particles (also referred to as “nicotine powder” or “particlescomprising nicotine”) and optional flavour particles. The nicotinepowder capsule may contain a predetermined amount of nicotine particlesand optional flavour particles. The capsule may contain enough nicotineparticles to provide at least 2 inhalations or “puffs” of nicotine, orat least about 5 inhalations or “puffs” of nicotine, or at least about10 inhalations or “puffs” of nicotine. Preferably, the capsule maycontain enough nicotine particles to provide from about 5 to 50inhalations or “puffs” of nicotine, or from about 10 to 30 inhalationsor “puffs” of nicotine. Each inhalation or “puff” of nicotine particlesmay deliver from about 0.1 mg to about 3 mg of nicotine particles to thelungs of the user or from about 0.2 mg to about 2 mg of nicotineparticles to the lungs of the user or about 1 mg of nicotine particlesto the lungs of the user. Preferably, about 50 to about 150 microgramsof nicotine is delivered to the lungs of the user with each “puff”.

The capsule may hold or contain at least about 5 mg of nicotineparticles or at least about 10 mg of nicotine particles. Preferably, thecapsule may hold or contains less than about 30 mg of nicotine particlesor less than about 25 mg of nicotine particles, or less than 20 mg ofnicotine particles. The capsule may hold or contain from about 5 mg toabout 30 mg of nicotine particles or from about 10 mg to about 20 mg ofnicotine particles.

When flavour particles are blended or combined with the nicotineparticles within the capsule, the flavour particles are present in anamount that provides the desired flavour to each inhalation or “puff”delivered to the user.

The particles comprising nicotine may have any useful size distributionfor inhalation delivery preferentially into the lungs of a user. Thepowder system may have at least about 40% or at least about 60%, or atleast about 80%, by weight of the nicotine of the powder systemcomprised in particles having a particle size of about 10 micrometres orless. The powder system may have at least about 40% or at least about60%, or at least about 80%, by weight of the nicotine of the powdersystem comprised in particles having a particle size of about 5micrometres or less. The powder system may have at least about 40% or atleast about 60%, or at least about 80%, by weight of the nicotine of thepowder system comprised in particles having a particle size in a rangefrom about 1 micrometer to about 3 micrometres.

Nicotine in the nicotine powder or nicotine particles may be apharmaceutically acceptable free-base nicotine, or nicotine salt ornicotine salt hydrate. Useful nicotine salts or nicotine salt hydratesinclude; nicotine pyruvate, nicotine citrate, nicotine aspartate,nicotine lactate, nicotine bitartrate, nicotine salicylate, nicotinefumarate, nicotine mono-pyruvate, nicotine glutamate or nicotinehydrochloride, for example. The compound combining with nicotine to formthe salt or salt hydrate may be chosen based on its expectedpharmacological effect. For example: nicotine salicylate may beadministered for fever relief, as an anti-inflammatory or painkiller;nicotine fumarate may be administered to treat multiple sclerosis; andnicotine mono-pyruvate may be administered for treating chronicobstructive pulmonary disease (COPD) or for weight loss.

The particles comprising nicotine may include an amino acid. Preferablythe amino acid may be leucine such as, L-leucine. Providing an aminoacid such as L-leucine with the particles comprising nicotine,especially coating the nicotine or particles comprising nicotine withthe amino acid, may reduce adhesion forces of the particles comprisingnicotine and may reduce attraction between nicotine particles and thusreduce agglomeration of nicotine particles. Similarly, adhesion forcesto particles comprising flavour may also reduced thus agglomeration ofnicotine particles with flavour particles may also reduced. The powdersystem described herein thus may be a free flowing material and possessa stable relative particle size of each powder component even when thenicotine particles and the flavour particles are combined.

Preferably, the nicotine may be a surface modified nicotine salt wherethe nicotine salt particle is a coated particle. A preferred coatingmaterial is L-leucine. One particularly useful nicotine powder is anL-leucine coated nicotine bitartrate.

The nicotine powder capsule may optionally include flavour particles.The flavour particles may have any useful size distribution forinhalation delivery selectively into the mouth or buccal cavity of auser.

The powder system may have at least about 40% or at least about 60%, orat least about 80%, by weight of the flavour of the powder systemcomprised in particles having a particle size of about 20 micrometres orgreater. The powder system may have at least about 40% or at least about60%, or at least about 80%, by weight of the flavour of the powdersystem comprised in particles having a particle size of about 50micrometres or greater. The powder system may have at least about 40% orat least about 60%, or at least about 80%, by weight of the flavour ofthe powder system comprised in particles having a particle size in arange from about 50 micrometer to about 150 micrometres.

Flavourants or flavours may be provided as a solid flavour (at roomtemperature of about 22 degrees centigrade and one atmosphere pressure)and may include flavour formulations, flavour-containing materials andflavour precursors. The flavourant may include one or more naturalflavourants, one or more synthetic flavourants, or a combination ofnatural and synthetic flavourants. Flavourants as described herein areorganoleptic compounds, compositions, or materials that are selected andutilized to alter or are intended to alter the taste or aromacharacteristics of the nicotine powder component during consumption orinhalation thereof.

Flavourants or flavours refer to a variety of flavour materials ofnatural or synthetic origin. They include single compounds and mixtures.Preferably the flavour or flavourant has flavour properties that enhancethe experience of the nicotine powder component during consumption.Preferably, the flavour is chosen to provide an experience similar tothat resulting from smoking a combustible smoking article. For example,the flavour or flavourant may enhance flavour properties such as mouthfullness and complexity. Complexity is generally known as the overallbalance of the flavour being richer without dominating single sensoryattributes. Mouth fullness is described as perception of richness andvolume in the mouth and throat of the consumer.

Suitable flavours include, but are not limited to, any natural orsynthetic flavour, such as tobacco, smoke, menthol, mint (such aspeppermint and spearmint), chocolate, licorice, citrus and other fruitflavours, gamma octalactone, vanillin, ethyl vanillin, breath freshenerflavours, spice flavours such as cinnamon, methyl salicylate, linalool,bergamot oil, geranium oil, lemon oil, and ginger oil, and the like.

Other suitable flavours may include flavour compounds selected from thegroup consisting of an acid, an alcohol, an ester, an aldehyde, aketone, a pyrazine, combinations or blends thereof and the like.Suitable flavour compounds may be selected, for example, from the groupconsisting of phenylacetic acid, solanone, megastigmatrienone,2-heptanone, benzylalcohol, cis-3-hexenyl acetate, valeric acid, valericaldehyde, ester, terpene, sesquiterpene, nootkatone, maltol,damascenone, pyrazine, lactone, anethole, iso-s valeric acid,combinations thereof, and the like.

Further specific examples of flavours may be found in the currentliterature, and are well-known to the person skilled in the art offlavouring, i.e. of imparting an odor or taste to a product.

The flavourant may be a high potency flavourant, and may be used anddetected at levels that would result in less than 200 parts per millionin inhalation air flow. Examples of such flavourants are key tobaccoaroma compounds such as beta-damascenone, 2-ethyl-3,5-dimethylpyrazine,phenylacetaldehyde, guaiacol, and furaneol. Other flavourants may onlybe sensed by humans at higher concentration levels. These flavourants,which are referred to herein as the lower potency flavourants, aretypically used at levels that results in orders of magnitude higheramounts of flavourant released into the inhalation air. Suitable lowerpotency flavourants include, but are not limited to, natural orsynthetic menthol, peppermint, spearmint, coffee, tea, spices (such ascinnamon, clove and ginger), cocoa, vanilla, fruit flavours, chocolate,eucalyptus, geranium, eugenol and linalool.

The particles comprising flavour may include a compound to reduceadhesion forces or surface energy and resulting agglomeration. Theflavour particle may be surface modified with an adhesion reducingcompound to form a coated flavour particle. One preferred adhesionreducing compound is magnesium stearate. Providing an adhesion reducingcompound such as magnesium stearate with the flavour particle,especially coating the flavour particle, reduces adhesion forces of theparticles comprising flavour and may reduce attraction between flavourparticles and thus reduce agglomeration of flavour particles. Thusagglomeration of flavour particles with nicotine particles may also bereduced. The powder system described herein thus may possess a stablerelative particle size of the particles comprising nicotine and theparticles comprising flavour even when the nicotine particles and theflavour particles are combined. The powder system preferably is freeflowing.

Conventional formulations for dry powder inhalation typically containcarrier particles that serve to increase the fluidization of the activeparticles since the active particles may be too small to be influencedby simple airflow though the inhaler. These carrier particles areusually a saccharide such as lactose or mannitol that have a particlesize greater than about 50 micrometres. The carrier particles areutilized to improve the dose uniformity by acting as a diluent orbulking agent in a formulation. Carrier particles such as lactose ormannitol are not considered flavourants or flavour material in thisdisclosure.

The powder system utilized with the nicotine powder delivery systemdescribed herein may be carrier-free or substantially free of asaccharide such as lactose or mannitol. Being carrier-free orsubstantially free of a saccharide such as lactose or mannitol may allowthe nicotine and to be inhaled and delivered to the user's lungs atinhalation or airflow rates that are similar to typical smoking regimeinhalation or airflow rates. In addition, since the nicotine iscarrier-free or substantially free of a saccharide such as lactose ormannitol, the airflow path of the inhaler may have simple geometry or asimple configuration.

The nicotine powder and a flavour may be combined in a single capsule.As described above, the nicotine powder and a flavour may each havereduced adhesion forces that result in a stable powder formulation wherethe particle size of each component does not substantially change whencombined. Alternatively, the powder system may include nicotineparticles contained within a single capsule and the flavour particlescontained within a second capsule.

The nicotine particles and a flavour particles may be combined in anyuseful relative amount so that the flavour particles are detected by theuser when consumed with the nicotine particles. Preferably the nicotineparticles and flavour particles may form at least about 90% wt or atleast about 95% wt or at least about 99% wt or 100% wt of the totalweight of the powder system.

This nicotine powder delivery system and inhaler may be less complex andmay have a simplified powder storage and airflow path as compared toexisting DPIs. The nicotine powder delivery system and inhaler describedherein may not need a typical carrier ingredient, such as lactose, asdescribed above. Advantageously, rotation of the nicotine powder capsulewithin the inhaler aerosolizes the nicotine powder and may assist inmaintaining a free flowing powder. Thus, the inhaler does not requirethe typical high inhalation rates of conventional DPIs to deliver thedry nicotine powders described above deep into the lungs.

The nicotine inhaler according to this invention operates may use a flowrate of less than about 5 L/min or less than about 3 L/min or less thanabout 2 L/min or about 1.6 L/min. Preferably, the flow rate is in arange from about 1 L/min to about 3 L/min or from about 1.5 L/min toabout 2.5 L/min. Preferably, the inhalation rate or flow rate is similarto that of Health Canada smoking regime, that is about 1.6 L/min.

The nicotine inhaler described herein may be used by a consumer likesmoking a conventional cigarette or vaping an electronic cigarette. Suchsmoking or vaping is characterized by two steps: a first step duringwhich a small volume containing the full amount of nicotine desired bythe consumer is drawn into the mouth cavity, followed by a second stepduring which this small volume comprising the aerosol comprising thedesired amount of nicotine is further diluted by fresh air and drawndeeper into the lungs. Both steps are controlled by the consumer. Duringthe first inhalation step the consumer may determine the amount ofnicotine to be inhaled. During the second step, the consumer maydetermine the volume for diluting the first volume to be drawn deeperinto the lungs, maximizing the concentration of active agent deliveredto the airway epithelial surface. This smoking mechanism is sometimescalled “puff-inhale-exhale”.

A piercing element, such as a metal or rigid needle, forms a singleaperture through the capsule. The capsule is received within thenicotine powder receptacle and the piercing element may pierce theaperture into the capsule that is received in the nicotine powderreceptacle. The piercing element may pass through the end cap element.

The piercing element may be included on or within an article orpackaging container housing a plurality of nicotine powder deliverysystems. The piercing element may be fixed to the article or packagingcontainer. Preferably, a single piercing element may be fixed to thearticle or packaging container and the user may manually puncture thenicotine capsule contained within the nicotine powder inhaler byinserting the piercing element through the nicotine powder inhaler endcap and into the nicotine capsule contained within the nicotine powderreceptacle to form the single aperture through the capsule. The userthen withdraws the nicotine powder inhaler from the piercing element andconsumes the nicotine powder.

Alternatively, there may be an equal number of piercing elements andnicotine powder delivery systems within an article or packagingcontainer. A piercing element is registered and inserted into eachrespective nicotine powder inhaler end cap and into the nicotine capsulecontained within the nicotine powder receptacle to form the singleaperture though each capsule. The user then withdraws each nicotinepowder inhaler from its respective piercing element and consumes thenicotine powder.

All scientific and technical terms used herein have meanings commonlyused in the art unless otherwise specified. The definitions providedherein are to facilitate understanding of certain terms used frequentlyherein.

The terms “upstream” and “downstream” refer to relative positions ofelements of the inhaler described in relation to the direction ofinhalation air flow as it is drawn through the body of the inhaler froma distal end portion to the mouthpiece portion.

As used herein, the singular forms “a”, “an”, and “the” encompassembodiments having plural referents, unless the content clearly dictatesotherwise.

As used herein, “or” is generally employed in its sense including“and/or” unless the content clearly dictates otherwise. The term“and/or” means one or all of the listed elements or a combination of anytwo or more of the listed elements.

As used herein, “have”, “having”, “include”, “including”, “comprise”,“comprising” or the like are used in their open ended sense, andgenerally mean “including, but not limited to”. It will be understoodthat “consisting essentially of”, “consisting of”, and the like aresubsumed in “comprising,” and the like.

The words “preferred” and “preferably” refer to embodiments of theinvention that may afford certain benefits, under certain circumstances.However, other embodiments may also be preferred, under the same orother circumstances. Furthermore, the recitation of one or morepreferred embodiments does not imply that other embodiments are notuseful, and is not intended to exclude other embodiments from the scopeof the disclosure, including the claims.

FIGS. 1-2 are schematic diagrams of illustrative nicotine powderdelivery systems 1. FIGS. 3-4 are schematic diagrams of illustrativearticles 11, 12 packaging illustrative nicotine powder delivery systems1. The schematic drawings are not necessarily to scale and are presentedfor purposes of illustration and not limitation. The drawings depict oneor more aspects described in this disclosure. However, it will beunderstood that other aspects not depicted in the drawing fall withinthe scope and spirit of this disclosure.

Referring now to FIG. 1 and FIG. 2, the nicotine powder delivery systemincludes an inhaler article 1 that include an inhaler body 2 extendingbetween a mouthpiece portion 5 and a distal end portion 3 or end capelement 3. A nicotine powder receptacle 9 defining a capsule cavity 8 isdisposed within the inhaler body 2 and between the mouthpiece portion 5and the distal end portion 3. An air inlet port 4 extends through theinhaler body 2 and into the nicotine powder receptacle 9. A mouthpieceair channel 10 fluidly connects the nicotine powder receptacle 9 with aproximal end of the mouthpiece 5. A nicotine powder capsule 6 isdisposed within the nicotine powder receptacle 9. Particles comprisingnicotine 7 and optional particles comprising flavour is disposed withinthe nicotine powder capsule 6. As described above, a piecing element maypass thorough the distal end portion 3 or end cap element 3 and form asingle aperture into the nicotine powder capsule 6 for consumption. Airflow management through the air inlet ports 4 causes the nicotine powdercapsule 6 to rotate about its longitudinal axis when air flows from theair inlet port 4 downstream to the mouthpiece air channel 10.

FIG. 3 is a side view schematic diagram of an illustrative article 11packaging illustrative nicotine powder delivery systems 1. The article11 includes a container 15 that contains a plurality of nicotine powderdelivery systems 1 and a single piercing element 13. A user removes thenicotine powder delivery system 1 from the container 15 and inserts theend cap element 3 of the nicotine powder delivery system 1 onto thepiercing element 13 until the piercing element 13 pierces through thecapsule 6 forming a single aperture through the capsule 6. Then the userremoves the pierced nicotine powder delivery system 1 from the piercingelement 13 and consumes the nicotine powder. The piercing element 13 isfixed to the article 11. The nicotine powder delivery system 1 beingpierced is shown in cross-section to illustrate the location of thepiercing element 13.

FIG. 4 is a top view schematic diagram of an illustrative article 12packaging illustrative nicotine powder delivery systems 1. FIG. 5 is aside view schematic diagram of an illustrative article 12 packagingillustrative nicotine powder delivery systems 1. The article 12 includesa container 15 that contains a plurality of nicotine powder deliverysystems 1 and an equal number of piercing elements 13 and nicotinepowder delivery systems 1 within the packaging container 12.

Here the piercing element 13 is preloaded onto each nicotine powderdelivery system 1 so that each piercing element passes through thecapsule 6 forming a single aperture through the capsule 6. The userremoves the pierced nicotine powder delivery system 1 from the piercingelement 13 and consumes the nicotine powder. The plurality of piercingelements 13 are fixed to the article 12. One nicotine powder deliverysystem 1 is shown in cross-section to illustrate the location of therespective piercing element 13. The piercing element 13 is registeredand inserted into each respective nicotine powder inhaler end cap 3 andinto the nicotine capsule 6 contained within the nicotine powderreceptacle. The user then withdraws each nicotine powder inhaler 1 fromits respective piercing element 13 and consumes the nicotine powder.

The invention claimed is:
 1. A nicotine powder delivery system,comprising: an inhaler article extending from a proximal end to a distalend opposite of the proximal end and having a length therebetween, theinhaler article comprising: a tubular inhaler body extending between theproximal end and the distal end, the tubular inhaler body comprising amouthpiece portion disposed at the proximal end and a distal end portiondisposed at the distal end; a nicotine powder receptacle disposed withinthe tubular inhaler body, between the mouthpiece portion and the distalend portion; an air inlet port extending through the tubular inhalerbody and into the nicotine powder receptacle; a mouthpiece air channelfluidly connecting the nicotine powder receptacle with a proximal end ofthe mouthpiece portion; an end cap element disposed in the distal endportion of the tubular inhaler body, the end cap element formed of apierceable material that substantially closes a hole formed in thematerial; and a nicotine powder capsule having a longitudinal axis andcontaining nicotine powder, disposed within the nicotine powderreceptacle, wherein the nicotine powder capsule rotates about thelongitudinal axis when air flows from the air inlet port to themouthpiece air channel, wherein the end cap element is configured for apiercing element to pass through the end cap element to form a singleaperture in a wall of the nicotine powder capsule; and wherein theend-cap element has a resistance to draw (RTD) from about 120 mm WG toabout 200 mm WG.
 2. The nicotine powder delivery system of claim 1,wherein the air inlet port is off-set from the longitudinal axis of thenicotine powder capsule.
 3. The nicotine powder delivery systemaccording to claim 1, wherein the nicotine powder receptacle has acircular cross-sectional shape and the air inlet port is tangential tothe nicotine powder receptacle.
 4. The nicotine powder delivery systemaccording to claim 1, wherein the air inlet port comprises a first airinlet port and a second air inlet port.
 5. The nicotine powder deliverysystem of claim 4, wherein the nicotine powder receptacle has a circularcross-sectional shape and the first air inlet port is tangential to thenicotine powder receptacle and the second air inlet port is tangentialto the nicotine powder receptacle.
 6. The nicotine powder deliverysystem of claim 5, wherein the first air inlet port opposes the secondair inlet port.
 7. The nicotine powder delivery system according toclaim 1, wherein the nicotine powder receptacle has a circularcross-sectional shape and a first diameter and the nicotine powdercapsule has a second diameter that is less than the first diameter, andthe second diameter is in a range from about 80% to about 99% of thefirst diameter.
 8. The nicotine powder delivery system according toclaim 1, wherein the nicotine powder delivery system has a resistance todraw (RTD) in a range from about 50 mm WG to about 100 mm WG.
 9. Thenicotine powder delivery system according to claim 1, wherein thenicotine powder comprises particles comprising nicotine and having amass median aerodynamic diameter in a range from about 1 micrometres toabout 3 micrometres.
 10. The nicotine powder delivery system accordingto claim 9, wherein the particles comprising nicotine comprises nicotinesalt or nicotine salt hydrate.
 11. The nicotine powder delivery systemaccording to claim 9, wherein the particles comprising nicotine comprisean amino acid coating.
 12. The nicotine powder delivery system accordingto claim 9, wherein the nicotine powder capsule contains particlescomprising flavour and having a mass median aerodynamic diameter ofabout 20 micrometres or greater, or in a range from about 50 micrometresto about 150 micrometres.
 13. The nicotine powder delivery systemaccording to claim 1, further comprising a piercing element comprising asingle needle constructed to pass through the end-cap element.
 14. Anarticle containing a plurality of the nicotine powder delivery systemsaccording to claim 1, wherein a piercing element comprising a singleneedle is fixed to the article and the piercing element is constructedto pass through the end-cap element and to pierce the nicotine powdercapsule of one of the plurality of nicotine powder delivery systems, andthe pierced nicotine powder delivery system is removable from thepiercing element and article for consumption.
 15. An article containinga plurality of the nicotine powder delivery systems according to claim1, wherein a plurality of piercing elements are fixed to the article,wherein the number of piercing elements is equal to the number ofnicotine powder delivery systems.
 16. The article according to claim 15,wherein each of the plurality of piercing elements is registered andinserted into a corresponding nicotine powder capsule and forming asingle aperture in the corresponding nicotine powder capsule.
 17. Anicotine powder delivery system comprising: an inhaler articlecomprising; an inhaler body extending between a mouthpiece portion and adistal end portion; a nicotine powder receptacle disposed within theinhaler body and between the mouthpiece portion and the distal endportion; an air inlet port extending through the inhaler body and intothe nicotine powder receptacle; a mouthpiece air channel fluidlyconnecting the nicotine powder receptacle with a proximal end of themouthpiece portion; an end cap element disposed in the distal endportion, the end cap element formed of a pierceable material comprisingcellulose acetate that substantially closes a hole formed in thepierceable material; and a nicotine powder capsule having a longitudinalaxis and containing nicotine powder, disposed within the nicotine powderreceptacle, wherein the nicotine powder capsule rotates about thelongitudinal axis when air flows from the air inlet port to themouthpiece air channel, wherein the end cap element is configured to bepierced by a piercing element to form a single aperture through a wallof the nicotine powder capsule.